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Active Not Recruiting NCT07888998

Evaluation of the Effect of a Low-FODMAP Diet on Gastrointestinal Symptoms and Inflammatory Markers in Fabry Patients

Conditions: Fabry Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Acibadem University

Location: Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine Istanbul Fatih

Summary

The aim of this randomized controlled study is to evaluate the effects of a six-week low-fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet on gastrointestinal symptoms, inflammatory biomarkers, nutritional status, and quality of life in pediatric and adult patients with Fabry disease. A total of 30 patients with genetically or laboratory-confirmed Fabry disease are planned to be enrolled and randomly assigned to either an intervention group receiving an individualized low-FODMAP diet or a control group continuing their habitual diet. Assessments will be conducted at baseline and after six weeks. Gastrointestinal symptoms, stool characteristics, quality of life, anthropometric measurements, body composition, dietary intake, and biochemical parameters, including inflammatory biomarkers, will be evaluated. The study aims to investigate whether a low-FODMAP diet may provide additional benefits in managing gastrointestinal manifestations and inflammation in patients with Fabry disease.

Eligibility Criteria

Inclusion Criteria: Patients with genetically or laboratory-confirmed Fabry disease. Patients without a diagnosis of chronic kidney disease. Patients who have not previously followed a special or therapeutic diet. Patients who are not pregnant or breastfeeding. Patients who provide informed consent to participate in the study. Exclusion Criteria: Patients with a diagnosis of chronic kidney disease. Patients who do not provide informed consent to participate in the study.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07888998). StuddyBuddy aggregates publicly available trial information.